Clinical Trials Logo
  1. Home
  2. Dentin Sensitivity
  3. NCT03232255
  4. Details
NCT03232255 Clinical Trial

Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

Dentin Sensitivity Clinical Trial

Official title:
Clinical Benefit of a Mouthrinse for the Treatment of Dentine Hypersensitivity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03232255
Other study ID # 100080
Secondary ID
Status Completed
Phase N/A
First received July 25, 2017
Last updated January 2, 2018
Start date August 25, 2017
Est. completion date December 7, 2017

Study information
Verified date January 2018
Source InQpharm Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to evaluate the benefit and tolerability of a Mouthrinse (IQP-OLP-101) in the treatment of dentine hypersensitivity.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 7, 2017
Est. primary completion date December 7, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1. At least one hypersensitive tooth in everyday life after PAV 1 in-office visit

2. At least one hypersensitive tooth in everyday life with a regular pain perception of at least 2 times per week after PAV 1 visit

3. At least one tooth with dentine hypersensitivity to air stimulation ? VAS = 40mm at study entry

4. Any sensitive tooth showing exposure of cervical dentine (gum recession) and no acute signs of caries on the exposed root

5. For subjects entering the study at stage PAR-control: good healing of the periodontal surgery site, cause of pain must not be the result of the periodontal surgery

6. Age = 18 years and = 75 years

7. Willing and able to attend the on-study visits

8. Willing and able to understand and to follow the study procedures and instructions

9. Good oral hygiene throughout the study

10. Written informed consent before participation in the study

11. Subjects have undergone dental hygiene treatment immediately prior to study inclusion (except subjects entering the study at stage PAR-control)

Exclusion Criteria:

1. Hypersensitivity only due to sweets

2. Allergic reactions to any ingredients of InQpharm Mouthrinse e.g. chlorhexidine, zinc lactate

3. Professional desensitizing therapy during the previous 3 months; GLUMA (glutaraldehyde/hydroxyethyl methacrylate) desensitizer application within 6 months

4. Chronic systemic anti-inflammatory and analgesic medications

5. Systemic disorders causing or predisposing to dental (e.g. dry mouth, reflux, eating disorders, etc.)

6. Teeth or supporting structures with any other painful pathology or defect

7. Subject with poor health conditions

8. Concurrent participation in another clinical trial

9. Pregnant or lactating women

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Mouthrinse (IQP-OLP-101)
Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.

Locations
Country Name City State
Germany Praxisklinik ORS Fellbach

Sponsors (1)
Lead Sponsor Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in dentine hypersensitivity Assessed by subjects using VAS 28 days
See also
  Status Clinical Trial Phase
Completed NCT02753075 - A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice. N/A
Completed NCT06045026 - A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management N/A
Completed NCT02861664 - Assessment of the Efficacy of an Experimental Occlusion Technology Dentifrice in Dentinal Hypersensitivity N/A
Completed NCT02542943 - Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Dentinal Hypersensitivity N/A
Completed NCT02226562 - Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity Phase 2
Completed NCT02919202 - Clinical Trial to Compare the Efficacy of a Fluoride Gel and a Dental Bonding Agent in Treatment of Tooth Sensitivity N/A
Not yet recruiting NCT04485299 - Clinical Assessment of Bifluorid 10 vs Varnish Fluoride on The Exposed Hypersensitive Cervical Dentin in Adult Patient Phase 2/Phase 3
Completed NCT02931734 - Assessment of Different Protocols for Cervical Dentin Hypersensitivity Treatment N/A
Completed NCT02923895 - To Investigate the Efficacy of an Occluding Dentifrice in Dentinal Hypersensitivity (DH) Phase 4
Withdrawn NCT03361774 - A Clinical Method Development Study to Characterise The Efficacy of a Dentifrice For The Relief Of Dentin Hypersensitivity Phase 2
Completed NCT02924350 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity (DH) N/A
Completed NCT05083052 - Propolis in Reducing Dentin Hypersensitivity N/A
Active, not recruiting NCT06150573 - A Study Assessing the Effects of an Experimental Dentifrice in Maintaining Tooth Color Following Tooth Bleaching N/A
Completed NCT02937623 - To Evaluate the Efficacy of an Experimental Dissolvable Strip in Rapidly Relieving Dentinal Hypersensitivity (DH) N/A
Completed NCT02612064 - The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity N/A
Completed NCT02293044 - A Study to Evaluate the Safety and Efficacy of an Oxalate Strip on Adjacent Teeth With Dentinal Hypersensitivity N/A
Completed NCT02128633 - Effectiveness of a Homecare Dentin Hypersensitivity Gel Phase 2/Phase 3
Completed NCT03310268 - A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity N/A
Completed NCT05750745 - A Clinical Study to Evaluate the Efficacy of a Stannous Fluoride Toothpaste for the Relief of Dentine Hypersensitivity in a Chinese Population N/A
Not yet recruiting NCT06417580 - Effect of Pregabalin Gel in Controlling Cervical Dentin Hypersensitivity Phase 2